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Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01363063
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date March 6, 2018
Study Start Date  ICMJE December 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
Discomfort Measurement on a Visual Analogue Scale [ Time Frame: 15 minutes post-dose ]
Following administration of each treatment, subjects completed a visual analogue scale (VAS) (ranging from "no discomfort" to "severe discomfort") at 1, 5, 10 and 15 minutes post-dose. If after the 15 minute VAS assessment discomfort was still present the subject was asked to complete further VAS assessments, at 5 minute intervals, until the discomfort had dissipated.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
Discomfort Measurement on a Visual Analogue Scale [ Time Frame: 1, 5, 10 and 15 minutes post-dose ]
Following administration of each treatment, subjects completed a visual analogue scale (VAS) (ranging from "no discomfort" to "severe discomfort") at 1, 5, 10 and 15 minutes post-dose. If after the 15 minute VAS assessment discomfort was still present the subject was asked to complete further VAS assessments, at 5 minute intervals, until the discomfort had dissipated.
Change History Complete list of historical versions of study NCT01363063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Official Title  ICMJE A Phase 1, Double-Blind, Study of the Tolerability of Formulations of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Brief Summary

This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each subject participated in only one part of the study. In Part A subjects received one dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril, in a randomized manner. In Part B subjects were randomized to receive a single intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study, subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a post-study medical was performed prior to discharge.

The objective of this study was to compare the tolerability of formulations of ketorolac tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy volunteers.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Ketorolac tromethamine
    One dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril
  • Drug: Ketorolac tromethamine
    One dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg Ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril
Study Arms  ICMJE
  • Experimental: Ketorolac tromethamine (Part A)
    Intervention: Drug: Ketorolac tromethamine
  • Experimental: Ketorolac tromethamine (Part B)
    Intervention: Drug: Ketorolac tromethamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers, aged 18 to 60 years inclusive
  • Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
  • All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilization) throughout the study period
  • Subject had given signed informed consent
  • Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
  • Subject's medical history was considered normal, with no clinically significant abnormalities
  • Subject was considered to be in good health in the opinion of the Investigator, as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
  • Subject's pre-study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
  • Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
  • Body weight of at least 60 kg

Exclusion Criteria:

  • Subject had had a clinically significant illness in the four weeks before screening
  • Use of prescribed medications in the three weeks prior to dosing or over-the-counter preparations for seven days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
  • Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
  • Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
  • Current tobacco use or a history of smoking within the past five years
  • Subject was in the opinion of the Investigator not suitable to participate in the study
  • Subject had participated in any clinical study with an investigational drug/device within three months prior to dosing
  • Subject had a positive result of human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen
  • Subject had had a serious adverse reaction or significant hypersensitivity to any drug
  • Subject had donated 500 mL or more of blood within the three months prior to screening
  • Any history of co-existing nasal polyps, NSAID sensitivity and asthma
  • Allergic reaction to aspirin or other NSAIDs
  • Current upper respiratory tract infection or other respiratory tract condition that could have interfered with the absorption of the nasal spray or with the assessment of adverse events (AEs)
  • Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
  • Use of a monoamine oxidase inhibitor in the 14 days prior to study entry
  • Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
  • Anemia due to unexplained or known gastrointestinal bleeding
  • History of asthma or any other chronic pulmonary disorder
  • Renal impairment or a risk of renal failure due to volume depletion
  • Known sensitivity to lidocaine hydrochloride
  • Previous history of nasal surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363063
Other Study ID Numbers  ICMJE ROX 2006-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Egalet Ltd
Study Sponsor  ICMJE Egalet Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cyril Clarke, BSc, MB BS, MFPM ICON Developmental Solutions
PRS Account Egalet Ltd
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP